Quantitation of T-lymphocyte Subsets Using the CELL-DYN Sapphire Automated Haematology Analyser / 임상검사와정도관리

BACKGROUND: Quantitative analysis of T-lymphocyte subsets is used to assess immune competency. Traditionally, T-lymphocyte subset analysis has been performed using flow cytometry, which requires complex instrumentation and relatively skilled manual operation. We evaluated the performance of an automated haematology analyser, the CELL-DYN Sapphire (CD Sapphire; Abbott Laboratories, USA) for T-lymphocyte subset analysis. METHODS: The precision and linearity obtained using the CD Sapphire was evaluated. T-lymphocyte subsets in blood samples from 120 patients were quantified using CD Sapphire and flow cytometry (Cytomics FC 500; Beckman-Coulter, France). The time required for complete T cell subset analysis using both methods was also evaluated. RESULTS: Results of CD Sapphire-based quantitation of CD3+, CD3+CD4+, and CD3+CD8+ cells showed intra-assay CV of less than 5% for precision and displayed linearity in the ranges of 84 to 5364, 41 to 2615, and 44 to 2800 cells/microL, respectively. There was good correlation among the CD3+, CD3+CD4+, and CD3+CD8+ cell counts as well as in the CD4/CD8 ratio (r=0.987, 0.982, 0.982, and 0.980, respectively) using CD Sapphire and flow cytometry. The mean turnaround time for the CD Sapphire (10.0+/-0.5 minutes) was significantly less than that for flow cytometry (111.8+/-8.4 minutes, P<0.001). CONCLUSIONS: T cell subset analysis using the CD Sapphire gives excellent performance and consistent results that correlate well with those obtained by flow cytometry. We conclude that this time-efficient method can replace conventional flow cytometric methods used for measuring T cell subsets.

Evaluation of CELL-DYN Sapphire Hematology Analyzer / 임상검사와정도관리

BACKGROUND: CELL-DYN Sapphire (Abbott Diagnostics, Santa Clara, CA, USA) hematology analyzer is based on laser multi angle polarized scatter separation, focused flow impedance and fluorescent flow cytometry. In order to assess the usefulness of this newly introduced analyzer, we evaluated the precision and correlation of complete blood count including white blood cell differential count and reticulocyte count of CELL-DYN Sapphire instrument. METHODS: Patient samples ordered for complete blood count and white blood cell differential count and CELL-DYN 29 Plus control samples were used. We evaluated the precision of complete blood count and WBC differential count and analyzed correlation of these parameters for comparison with ADVIA 120 (Bayer corporation, Tarrytown, NY, USA) and manual count. We additionally evaluated reticulocyte parameters for precision and comparison with ADVIA 120. RESULTS: Short term precisions showed low coefficient of variation (CV) values for all CBC parameters including lower than 3% CV values for neutrophil and lymphocyte count. Long term precision showed lower than 4% CV values for all CBC and WBC differential count except for basophils. Comparison with ADVIA 120 showed good correlation for CBC except for MCHC. Good correlation was confirmed in all differential counts except for basophils. Comparison with manual WBC differential count showed good correlation except for monocyte and eosinophil. CONCLUSIONS: CELL-DYN Sapphire has high precision and good correlation with ADVIA 120 and manual count. CELL-DYN Sapphire is an exceptional instrument for CBC with WBC differentials and reticulocyte counting.

Evaluation of CELL-DYN Sapphire Hematology Analyzer / 임상검사와정도관리

BACKGROUND: CELL-DYN Sapphire (Abbott Diagnostics, Santa Clara, CA, USA) hematology analyzer is based on laser multi angle polarized scatter separation, focused flow impedance and fluorescent flow cytometry. In order to assess the usefulness of this newly introduced analyzer, we evaluated the precision and correlation of complete blood count including white blood cell differential count and reticulocyte count of CELL-DYN Sapphire instrument. METHODS: Patient samples ordered for complete blood count and white blood cell differential count and CELL-DYN 29 Plus control samples were used. We evaluated the precision of complete blood count and WBC differential count and analyzed correlation of these parameters for comparison with ADVIA 120 (Bayer corporation, Tarrytown, NY, USA) and manual count. We additionally evaluated reticulocyte parameters for precision and comparison with ADVIA 120. RESULTS: Short term precisions showed low coefficient of variation (CV) values for all CBC parameters including lower than 3% CV values for neutrophil and lymphocyte count. Long term precision showed lower than 4% CV values for all CBC and WBC differential count except for basophils. Comparison with ADVIA 120 showed good correlation for CBC except for MCHC. Good correlation was confirmed in all differential counts except for basophils. Comparison with manual WBC differential count showed good correlation except for monocyte and eosinophil. CONCLUSIONS: CELL-DYN Sapphire has high precision and good correlation with ADVIA 120 and manual count. CELL-DYN Sapphire is an exceptional instrument for CBC with WBC differentials and reticulocyte counting.

Evaluation of the Abbott Cell-Dyn Sapphire Hematology Analyzer / 대한진단검사의학회지

BACKGROUND: The performance of Cell-Dyn Sapphire (Abbott Diagnostic, USA) was compared to the Bayer Advia 2120 (Bayer Diagnostics, USA), Sysmex XE-2100 (Sysmex Corporation, Japan), and reference microscopy. METHODS: Three hundred samples for routine CBC and WBC differentials were randomly chosen for a comparison analysis. The Cell-Dyn Sapphire system was evaluated according to the linearity, imprecision, inter-instrument correlations, and white blood cell differential. RESULTS: The CBC parameters (WBC, RBC, hemoglobin and platelet) showed a significant linearity with correlation coefficients greater than 0.99 (P<0.0001). Coefficients of variation (CV) for withinrun and differential count of WBC were less than 5% except for Total CV for monocytes, eosinophils, and basophils and within-run CV for low valued eosinophils. The correlation coefficients with manual count were lower in monocytes, eosinophils, and basophils than in neutrophils and lymphocytes. The correlation with other hematology anlayzers was significant exclusive of basophils. CONCLUSIONS: These results demonstrate that the Cell-Dyn Sapphire has a good linearity, an acceptable reproducibility, a minimal carryover, and a comparable performance with the sysmex XE-2100 and Advia 2120.

CELL-DYN Sapphire Hematology Analyzer Performance Evaluation on Leukocyte Differential Counts / 임상검사와정도관리

BACKGROUND: Recent advances of hematology analyzers have improved performance of leukocyte differential counts and have reduced work load of clinical hematology laboratories. We evaluated CELL-DYN Sapphire (Abbott Diagnostics, Santa Clara, CA, USA) performance on leukocyte differential counts according to Clinical and Laboratory Standards Institute (CLSI) document H20-A. METHODS: We evaluated imprecision (short term imprecision from duplication of 147 patients' sample and long term imprecision from three level commercial controls) and accuracy (n=462) of leukocyte differential counts of CELL-DYN Sapphire and compared with those of Sysmex XE-2100 (TOA Medical Electronics Co., Kobe, Japan), ADVIA 120 (Bayer Diagnostics, Tarrytown, NY, USA) and Beckman Coulter LH 750 (Beckman Coulter, Miami, FL, USA). RESULTS: The imprecision of CELL-DYN Sapphire for neutrophils and lymphocytes differentials was low with coefficients of variation (CV) from 1.4 to 6.2%, but the imprecision for basophils was high with CV from 34.7 to 79.6%. The correlation with manual count was good in samples without flags (n=314), with the exception of basophils (r: neutrophils, 0.921; lymphocytes, 0.921; monocytes, 0.653; eosinophils, 0.869; basophils 0.272). The correlation with other hematology analyzers was high except basophils (r: neutrophils, 0.969-0.986; lymphocytes, 0.986-0.990; monocytes, 0.787-0.887; eosinophils, 0.881-0.962; basophils 0.086-0.327). CONCLUSION: The performance on leukocyte differential counts of CELL-DYN Sapphire is comparable to Sysmex XE-2100, ADVIA 120 and Beckman Coulter LH 750. In regards of enumeration of basophils, the comparison with manual counts and other hematology analyzers shows poor agreement.